CA2836405C - Gels nasaux de testosterone a liberation prolongee, methodes associees et systemes applicateurs multi-doses pre-remplis destines a une administration pernasale - Google Patents
Gels nasaux de testosterone a liberation prolongee, methodes associees et systemes applicateurs multi-doses pre-remplis destines a une administration pernasale Download PDFInfo
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- CA2836405C CA2836405C CA2836405A CA2836405A CA2836405C CA 2836405 C CA2836405 C CA 2836405C CA 2836405 A CA2836405 A CA 2836405A CA 2836405 A CA2836405 A CA 2836405A CA 2836405 C CA2836405 C CA 2836405C
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0043—Nose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
- A61P5/26—Androgens
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Endocrinology (AREA)
- Reproductive Health (AREA)
- Inorganic Chemistry (AREA)
- Diabetes (AREA)
- Gynecology & Obstetrics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Otolaryngology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Pregnancy & Childbirth (AREA)
- Neurology (AREA)
- Psychiatry (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Anesthesiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
Abstract
L'invention concerne des gels intranasaux de testostérone permettant une libération prolongée de testostérone dans la circulation systémique d'hommes et de femmes pour obtenir des taux sanguins efficaces constants de testostérone, sans induire de pic de testostérone non voulu dans les taux sanguins suite à l'administration pernasale. Les gels intranasaux de testostérone selon l'invention sont sans danger, pratiques à utiliser, bien tolérés, stables et peuvent être fabriqués facilement et reproductible à grande échelle. En outre, puisque les taux sanguins de testostérone supra-normaux et sous-normaux sont supposés être sensiblement maintenus à un minimum ou empêchés, et que les taux sériques de testostérone sont supposés rester sensiblement constants pendant la vie de la dose, c'est-à-dire que les gels intranasaux de testostérone selon l'invention permettent d'imiter les taux de testostérone physiologiques quotidiennement rythmiques normaux ou de restaurer les taux sanguins de testostérone à des taux de testostérone physiologiques quotidiennement rythmiques normaux, ces nouveaux gels conviennent, de manière unique, à une thérapie de remplacement de testostérone ou d'apport d'un complément de testostérone, et pour traiter efficacement des hommes chez qui on a diagnostiqué par exemple une déficience en testostérone, comme une faible libido sexuelle, un faible désir sexuel, une faible activité sexuelle, une faible fertilité, une faible spermatogenèse, une aspermatogenèse, une dépression et/ou un hypogonadisme, et des femmes chez qui on a diagnostiqué une dysfonction sexuelle, comme une faible libido sexuelle, un faible désir sexuel, une faible activité sexuelle, une faible réactivité du noyau amygdalien, une faible stimulation sexuelle, un trouble du désir sexuel hypo-actif (HSDD), un trouble de l'excitation sexuelle et/ou une anorgasmie. L'invention concerne également des méthodes et des applicateurs sans air multi-doses pré-remplis destinés à une administration pernasale des gels nasaux de testostérone selon l'invention.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA3034552A CA3034552C (fr) | 2011-05-15 | 2012-05-15 | Gels nasaux de testosterone a liberation prolongee, methodes associees et systemes applicateurs multi-doses pre-remplis destines a une administration pernasale |
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161486324P | 2011-05-15 | 2011-05-15 | |
| US61/486,324 | 2011-05-15 | ||
| US201161486634P | 2011-05-16 | 2011-05-16 | |
| US61/486,634 | 2011-05-16 | ||
| PCT/IB2012/001127 WO2012156822A1 (fr) | 2011-05-15 | 2012-05-15 | Gels nasaux de testostérone à libération prolongée, méthodes associées et systèmes applicateurs multi-doses pré-remplis destinés à une administration pernasale |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA3034552A Division CA3034552C (fr) | 2011-05-15 | 2012-05-15 | Gels nasaux de testosterone a liberation prolongee, methodes associees et systemes applicateurs multi-doses pre-remplis destines a une administration pernasale |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2836405A1 CA2836405A1 (fr) | 2012-11-22 |
| CA2836405C true CA2836405C (fr) | 2021-09-07 |
Family
ID=46579248
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA3034552A Active CA3034552C (fr) | 2011-05-15 | 2012-05-15 | Gels nasaux de testosterone a liberation prolongee, methodes associees et systemes applicateurs multi-doses pre-remplis destines a une administration pernasale |
| CA2836398A Active CA2836398C (fr) | 2011-05-15 | 2012-05-15 | Formulations intranasales bio-adhesives de gel de testosterone et leur utilisation pour traiter l'hypogonadisme chez les hommes |
| CA2836405A Active CA2836405C (fr) | 2011-05-15 | 2012-05-15 | Gels nasaux de testosterone a liberation prolongee, methodes associees et systemes applicateurs multi-doses pre-remplis destines a une administration pernasale |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA3034552A Active CA3034552C (fr) | 2011-05-15 | 2012-05-15 | Gels nasaux de testosterone a liberation prolongee, methodes associees et systemes applicateurs multi-doses pre-remplis destines a une administration pernasale |
| CA2836398A Active CA2836398C (fr) | 2011-05-15 | 2012-05-15 | Formulations intranasales bio-adhesives de gel de testosterone et leur utilisation pour traiter l'hypogonadisme chez les hommes |
Country Status (16)
| Country | Link |
|---|---|
| EP (3) | EP3977982A1 (fr) |
| JP (9) | JP6152092B2 (fr) |
| KR (9) | KR20200118228A (fr) |
| CN (4) | CN109481394B (fr) |
| AR (2) | AR089553A1 (fr) |
| AU (10) | AU2012257492A1 (fr) |
| BR (2) | BR112013029336B1 (fr) |
| CA (3) | CA3034552C (fr) |
| DK (1) | DK2714006T3 (fr) |
| EA (1) | EA201391701A1 (fr) |
| ES (1) | ES2859784T3 (fr) |
| IL (2) | IL229401A0 (fr) |
| MX (4) | MX2020008599A (fr) |
| PL (1) | PL2714006T3 (fr) |
| WO (2) | WO2012156820A1 (fr) |
| ZA (2) | ZA201309264B (fr) |
Families Citing this family (42)
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| US9757388B2 (en) | 2011-05-13 | 2017-09-12 | Acerus Pharmaceuticals Srl | Intranasal methods of treating women for anorgasmia with 0.6% and 0.72% testosterone gels |
| US20130040923A1 (en) | 2011-05-13 | 2013-02-14 | Trimel Pharmaceuticals Corporation | Intranasal lower dosage strength testosterone gel formulations and use thereof for treating anorgasmia or hypoactive sexual desire disorder |
| KR20200118228A (ko) * | 2011-05-15 | 2020-10-14 | 에이세러스 바이오파마 인크. | 비내용 테스토스테론 바이오-접착제 겔 제형 및 남성의 성선기능저하증을 치료하기 위한 그의 용도 |
| US8971800B2 (en) * | 2011-05-31 | 2015-03-03 | Qualcomm Incorporated | Methods and apparatus for improving NFC activation and data exchange reporting mechanisms |
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| RS62297B1 (sr) | 2011-11-23 | 2021-09-30 | Therapeuticsmd Inc | Prirodne kombinovane hormonske supstitucione formulacije i terapije |
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| GB0807605D0 (en) * | 2008-04-28 | 2008-06-04 | Diurnal Ltd | Lipid composition |
| KR20200118228A (ko) * | 2011-05-15 | 2020-10-14 | 에이세러스 바이오파마 인크. | 비내용 테스토스테론 바이오-접착제 겔 제형 및 남성의 성선기능저하증을 치료하기 위한 그의 용도 |
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